25 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LYMA Laser
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PRISM XPVT SYSTEM (210823)
FDA 510(k)
FDA Class 2
·Radiology
SOLUTION SYSTEM
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295086994·SOLUTION SYSTEM THINSHAFT REAMER 11mm DIA
PRISMAFLEX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPAZZ
FDA 510(k)
FDA Class 1
·Physical Medicine
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
PRISMAFLEX
FDA Adverse Event
Injury
·GAMBRO LUNDIA AB·Product code KDI·February 6, 2014
PRISMAFLEX
FDA Adverse Event
Death
·GAMBRO LUNDIA AB·Product code KDI·April 11, 2014
PRISMAFLEX
FDA Adverse Event
Injury
·GAMBRO LUNDIA AB·Product code KDI·November 2, 2012
PRISMAFLEX
FDA Adverse Event
Injury
·GAMBRO LUNDIA AB·Product code KDI·February 15, 2012
PRISMAFLEX
FDA Adverse Event
Injury
·GAMBRO LUNDIA AB·Product code KDI·December 23, 2013
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·August 12, 2011
CONE TIP URETERAL CATHETER
FDA Adverse Event
Malfunction
·COOK UROLOGICAL, INC.·Product code FAD·July 2, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 8, 2013
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·September 14, 2021
PRISMAFLEX
FDA Adverse Event
Injury
·GAMBRO LUNDIA AB·Product code KDI·February 6, 2014
PRISMAFLEX
FDA Adverse Event
Death
·GAMBRO LUNDIA AB·Product code KDI·January 10, 2014
PRISMAFLEX
FDA Adverse Event
Death
·GAMBRO LUNDIA AB·Product code KDI·January 3, 2014
PRISMAFLEX
FDA Adverse Event
GAMBRO LUNDIA AB·Product code KDI·February 6, 2014
PRISMAFLEX
FDA Adverse Event
Injury
·GAMBRO LUNDIA AB·Product code KDI·August 13, 2012